Open Label, Single-dose, Dose Escalating Evaluation of the Safety and Tolerability of DBI-001 in Patients With T. Pedis

Clinical Study Protocol Number DBI-201. Open Label, Single-dose, Dose Escalating Evaluation of the Safety and Tolerability of DBI-001 in Patients With Tinea Pedis

This is an open- label, single- dose, dose escalating evaluation of the safety and tolerability of three dose levels of DBI-001 in patients with Tinea pedis.

The purpose of the current protocol is to establish the safety and tolerability of a single application of J. lividum to the feet of patients with proven T. pedis. In addition, the effect of J liv on the T. pedis will also be evaluated.

Study Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: J. Lividum

Detailed Description

Open- label, single- dose, dose escalating evaluation of the safety and tolerability of three dose levels of DBI-001 in patients with Tinea pedis.

Study Objectives and Purpose The purpose of the study is to evaluate the safety and tolerability of DBI-001 in patients with Tinea pedis. Secondly to evaluate presence or persistence of J. lividum of DBI-001 following a single application of DBI-001. Thirdly to see the effect on the abundance of T. rubrum. Lastly to see the effect of a single application of DBI-001 on the signs and symptoms of interdigital T. pedis.

Tolerability will be evaluated through assessment of selected local signs and symptoms (pain / burning / stinging, pruritus, erythema, edema, and scabbing / crusting). Any local skin reaction that requires use of a concomitant therapy or study discontinuation will be reported

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Instituto Dermatologico y Cirugia de Piel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

Subjects must meet all of the following criteria to be included in the study:

1. Witnessed, signed informed consent approved by Institutional Review Board/Independent Ethics Committee.
2. A signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information.
3. Male Subjects of any race 18 years of age and older.
4. Subjects with a clinical diagnosis of interdigital T. pedis T. pedis interdigital defined as lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).
5. Provisionally confirmed diagnosis at baseline by a positive potassium hydroxide (KOH) wet mount at the clinical site.

6. The sum of the clinical signs and symptoms scores of the target lesion is at least 4 using the Grading and signs and symptoms of T. pedis detailed in section 6.6.1, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling/fissures or pruritus/burning (on a scale of 0-3, where 2 indicates moderate severity).

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Exclusion Criteria:

Subjects with the following will be excluded from this study:

1. Any dermatological conditions that could interfere with clinical evaluations.
2. Any underlying disease(s) or some other dermatological condition that requires the use of interfering topical or systemic therapy.

3. Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications applied to the foot:

   Topical astringents and abrasives (e.g. Burrow's solution) 1 week Topical antibiotics and antifungal on the infected area (e.g. Neomycin, Miconazole, Clotrimazole, Terbinafine) 2 weeks Anti-inflammatories, corticosteroids, topical immunomodulators (e.g. Pimecrolimus, Tacrolimus) 4 weeks

4. Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications:

Corticosteroids (including intramuscular injections) (e.g. Triamcinolone acetonide) 4 weeks Antibiotics (e.g. Tetracycline, Cephalosporins, etc.) and/or Antifungal agents (e.g. Fluconazole, Itraconazole, Terbinafine, etc.) 4 weeks Systemic immunomodulators (e.g. Cyclophosphamide, Azathioprine, Biologicals-Monoclonal Antibodies.

4 weeks

Subjects with the following will be excluded from this study:

1. Any dermatological conditions that could interfere with clinical evaluations.
2. Any underlying disease(s) or some other dermatological condition that requires the use of interfering topical or systemic therapy.

3. Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications applied to the foot:

   Topical astringents and abrasives (e.g. Burrow's solution) 1 week Topical antibiotics and antifungal on the infected area (e.g. Neomycin, Miconazole, Clotrimazole, Terbinafine) 2 weeks Anti-inflammatories, corticosteroids, topical immunomodulators (e.g. Pimecrolimus, Tacrolimus) 4 weeks

4. Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications:

   Corticosteroids (including intramuscular injections) (e.g. Triamcinolone acetonide) 4 weeks Antibiotics (e.g. Tetracycline, Cephalosporins, etc.) and/or Antifungal agents (e.g. Fluconazole, Itraconazole, Terbinafine, etc.) 4 weeks Systemic immunomodulators (e.g. Cyclophosphamide, Azathioprine, Biologicals-Monoclonal Antibodies. 4 weeks

5. Treatment of any type of cancer within the last 6 months.
6. History of any significant internal disease (which contraindicates use of live microbiome e.g. leukemia, liver failure, cardiovascular disease)
7. Subjects who are known to be allergic to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure.
8. AIDS or AIDS related complex by medical history.
9. Known or suspected immune suppressive medications or diseases.
10. Diabetes mellitus Type I or II by medical history.
11. Peripheral vascular disease based on medical history.
12. Any subject not able to meet the study attendance requirements.

13. Subjects who have participated in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cohort 1; Cohort 1 low dose of J. lividum	Drug: J. Lividum; Investigational Product; Other Names: Janthinobacterium lividum
Active Comparator: Cohort 2; Cohort 2 medium dose of J. lividum	Drug: J. Lividum; Investigational Product; Other Names: Janthinobacterium lividum
Active Comparator: Cohort 3; Cohort 3 - high dose of J. Lividum	Drug: J. Lividum; Investigational Product; Other Names: Janthinobacterium lividum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Tolerability	Tolerability will be evaluated through assessment local signs and symptoms. Scoring for Fissuring/Cracking, Erythema, Maceration, Scaling, Pruritus, Burning/Stinging: 0 = none (complete absence); = mild (slight); = moderate (definitely present); = severe (marked, intense)	Baseline (Day 1) to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy 1: Presence and Persistence of J. lividum	Proportion of samples at each time point in which J. lividum can be detected.	28 Days
Efficacy 2: Clinical Response	Changes in signs and symptoms of T. pedis Scoring Measure for Fissuring/Cracking, Erythema, Maceration, Scaling, Pruritus, Burning/Stinging: Scoring Measure: 0 = none (complete absence); = mild (slight); = moderate (definitely present); = severe (marked, intense)	28 Days

Collaborators and Investigators

• Sponsor: DermBiont, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2019
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Microbiome; Dysbiosis; Dermatophytes
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis
• Other Study ID Numbers: DBI-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No